Anti-inflammatory H1 Antihistamines Allergic Rhinitis

July 22, 2015 updated by: Stefan Cristian Vesa, Iuliu Hatieganu University of Medicine and Pharmacy

In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis

The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.

Study Overview

Status

Completed

Conditions

Detailed Description

Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.

We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.

Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.

The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.

Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).

A TSS<6 means a mild rhinitis, while a TSS> 6 represented a moderate severe one.

The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.

The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.

Clinical and biological evaluation were performed before and after treatment

Study Type

Interventional

Enrollment (Actual)

115

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • persistent allergic rhinitis

Exclusion Criteria:

  • the presence of asthma or nasal polyps,
  • acute and chronic upper respiratory infections,
  • administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: healthy volunteers
Active Comparator: Desloratadine
patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
administration of Desloratadine 5 mg/day for 4 weeks
Other Names:
  • Aerius
Active Comparator: Levocetirizine
patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks
administration of Levocetirizine 5 mg/day for 4 weeks
Other Names:
  • Xyzal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
efficacy of H1 antihistamines (patients evaluation)
Time Frame: 4 weeks
patients evaluation before and after 4-weeks treatment
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
Time Frame: 1.5 years
incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

July 17, 2015

First Submitted That Met QC Criteria

July 22, 2015

First Posted (Estimate)

July 24, 2015

Study Record Updates

Last Update Posted (Estimate)

July 24, 2015

Last Update Submitted That Met QC Criteria

July 22, 2015

Last Verified

July 1, 2015

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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